Validation Study of G4 User Interface

Simulated Usability Trial of the T-Slim Ambulatory Insulin Infusion Pump

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01142895

Acronym

Enrollment

Registered

2010-06-11

Start date

2010-05-31

Completion date

Unknown

Last updated

2010-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Brief summary

The purpose of this simulated useability study is to demonstrate the user interface and software design mitigate potential safety concerns.

Detailed description

These are the detailed descriptive planned outcomes of this useability study. * To demonstrate that human-interface design mitigations lead to effective, efficient, and safe use. * Validate that foreseeable misuse does not lead to a safety hazard or patient injury. * Validate the effectiveness and comprehension of critical warnings and alerts, including vibratory, auditory, and textual cues.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of diabetes mellitus

Outcome results